A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:21 - Any
Updated:10/26/2018
Start Date:April 18, 2018
End Date:March 2019
Contact:Deborah Scott, MS
Email:deborah.scott@durect.com
Phone:408-777-1417

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An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis

This is a research trial testing DUR-928 (an experimental medication). The purpose of this
trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928
in patients with moderate and severe alcoholic hepatitis (AH).


Inclusion Criteria:

1. Able to provide written informed consent (either from patient or patient's legally
acceptable representative)

2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2

3. Patients with alcoholic hepatitis defined as:

1. History of heavy alcohol abuse: > 40 g/day in females or > 60 g/day in males for
a minimum period of 6 months, AND

2. Consumed alcohol within 12 weeks of entry into the study, AND

3. Serum bilirubin > 3 mg/dL AND AST > ALT, but less than 300 U/L AND

4. MELD score between 11-30, inclusive

4. No evidence of active infection as determined by the investigator.

5. Women of child-bearing potential must utilize appropriate birth control throughout the
study duration.

6. Male patients must agree to use a medically acceptable method of contraception/birth
control throughout the study duration

Exclusion Criteria:

1. Other or concomitant cause(s) of liver disease as a result of:

1. Autoimmune liver disease

2. Wilson disease

3. Vascular liver disease

4. Drug induced liver disease

2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B

3. Any active malignancies other than curatively treated skin cancer (basal cell or
squamous cell carcinomas)

4. If female, known pregnancy, or has a positive serum pregnancy test, or
lactating/breastfeeding

5. Serum creatinine > 2.5 mg/dL

6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone
marrow, or stem cell etc.), other than cornea transplant

7. Stage 3 or greater encephalopathy by West Haven criteria
We found this trial at
7
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111 East Pearson Street
Chicago, Illinois 60611
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Atlanta, Georgia 30309
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Indianapolis, Indiana 46202
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Louisville, Kentucky 40202
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Miami, Florida 33136
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San Antonio, Texas 78215
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6367 Alvarado Court
San Diego, California 92118
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San Diego, CA
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